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ニュルンベルク・コード

The Nuremberg Code

池田光穂

ニュルンベルク・コード（ニュルンベルグコード） は、ニュルンベルグ綱領は、人体実験をおこなう際に必要な倫理的な原則をまとめて示したものである。ここでいう人体実験は、あらゆる臨床実践は実験的なト ライアル＝試行の性格をもつゆえ、倫理的な要件（つまりニュルンベルグコードが守られていれば）のもとでおこなわれる臨床行為は正当化されるという意味で ある。この原則は12の「ニュルンベルク継続裁判」のうちの最初の「ニュルンベルク医師裁判」の過程で生まれたと言われている。

The Nuremberg Code (German: Nürnberger Kodex) is a set of research ethics principles for human experimentation created as a result of the Nuremberg trials at the end of the Second World War.- Nuremberg Code.

1.被験者の自発的な同意が絶対に必要である。

このことは、被験者が、同意を与える法的な能力を持つべきこと、圧力や詐欺、欺瞞、脅迫、陰謀、その他の隠された強制や威圧による干渉を少しも受けること なく、自由な選択権を行使することのできる状況に置かれるべきこと、よく理解し納得した上で意思決定を行えるように、関係する内容について十分な知識と理 解力を有するべきことを意味している。後者の要件を満たすためには、被験者から肯定的な意思決定を受ける前に、実験の性質、期間、目的、実施の方法と手 段、起こっても不思議ではないあらゆる不都合と危険性、実験に参加することによって生ずる可能性のある健康や人格への影響を、被験者に知らせる必要があ る。

同意の質を保証する義務と責任は、実験を発案したり、指揮したり、従事したりする各々の個人にある。それは、免れて他人任せにはできない個人的な義務であ り責任である。

2.実験は、社会の福利のために実り多い結果を生むとともに、他の方法や手段では行えないものであるべきであり、無計画あるいは無駄に行うべきではない。

3.予想される結果によって実験の遂行が正当化されるように、実験は念入りに計画され、動物実験の結果および研究中の疾患やその他の問題に関する基本的な 知識に基づいて行われるべきである。

4.実験は、あらゆる不必要な身体的、精神的な苦痛や傷害を避けて行われるべきである。

5.死亡や障害を引き起こすことがあらかじめ予想される場合、実験は行うべきではない。ただし、実験する医師自身も被験者となる実験の場合は、例外として よいかも知れない。

6.実験に含まれる危険性の度合いは、その実験により解決される問題の人道上の重大性を決して上回るべきではない。

7.傷害や障害、あるいは死をもたらす僅かな可能性からも被験者を保護するため、周到な準備がなされ、適切な設備が整えられるべきである。

8.実験は、科学的有資格者によってのみ行われるべきである。実験を行う者、あるいは実験に従事する者には、実験の全段階を通じて、最高度の技術と注意が 求められるべきである。

9.実験の進行中に、実験の続行が耐えられないと思われる程の身体的あるいは精神的な状態に至った場合、被験者は、実験を中止させる自由を有するべきであ る。

10.実験の進行中に、責任ある立場の科学者は、彼に求められた誠実さ、優れた技能、注意深い判断力を行使する中で、実験の継続が、傷害や障害、あるいは 死を被験者にもたらしそうだと考えるに足る理由が生じた場合、いつでも実験を中止する心構えでいなければならない。

翻訳：笹栗俊之（福岡臨床研究倫理審査ネットワーク）
 1.The voluntary consent of the human subject is absolutely essential.

This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.

The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

2.The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3.The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.

4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5.No experiment should be conducted, where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8.The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9.During the course of the experiment, the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state, where continuation of the experiment seemed to him to be impossible.

10.During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

source: http://www.med.kyushu-u.ac.jp/recnet_fukuoka/houki-rinri/nuremberg_original.html .

旧・東ドイツの政治的イデオロギーの観点から、ニュ ルンベルグの戦争犯罪が戦後もきちんと克服されていないという告発はペーター・プシビルスキ（1981）『裁かれざるナチス : ニュルンベルク裁判とその後』を参照のこと。

●歴史的背景（すべてNuremberg Code.からの引用です）

（１）"The origin of the Nuremberg Code began in pre–World War II German politics, particularly during the 1930s and 1940s. The pre-war German Medical Association was considered to be a progressive yet democratic association with great concerns for public health, one example being the legislation of compulsory health insurance for German workers[citation?]. However, starting in the mid-1920s, German physicians, usually proponents of racial hygiene, were accused by the public and the medical society of unethical medical practices. The use of racial hygiene was supported by the German government in order to create an Aryan "master race", and to exterminate those who did not fit into their criteria. Racial hygiene extremists merged with National Socialism to promote the use of biology to accomplish their goals of racial purity, a core concept in the Nazi ideology. Physicians were attracted to the scientific ideology and aided in the establishment of National Socialist Physicians' League in 1929 to "purify the German medical community of 'Jewish Bolshevism'." Criticism was becoming prevalent; Alfons Stauder, member of the Reich Health Office, claimed that the "dubious experiments have no therapeutic purpose", and Fredrich von Muller, physician and the president of the Deutsche Akademie, joined the criticism.[1]"

（２）"In response to the criticism of unethical human experimentation, the Reich government issued "Guidelines for New Therapy and Human Experimentation" in Weimar, Germany. The guidelines were based on beneficence and non-maleficence, but also stressed legal doctrine of informed consent. The guidelines clearly distinguished the difference between therapeutic and non-therapeutic research. For therapeutic purposes, the guidelines allowed administration without consent only in dire situations, but for non-therapeutic purposes any administration without consent was strictly forbidden. However, the guidelines from Weimar were negated by Adolf Hitler. By 1942, the Nazi party included more than 38,000 German physicians, who helped carry out medical programs such as the Sterilization Law.[2]"

（３）"After World War II, a series of trials were held to hold members of the Nazi party responsible for a multitude of war crimes. The trials were approved by President Harry Truman on May 2, 1945 and were led by the United States, Great Britain, and the Soviet Union. They began on November 20, 1945 in Nuremberg, Germany, in what became known as the Nuremberg trials. In one of the trials, which became known as the "Doctors' Trial", German physicians responsible for conducting unethical medical procedures on humans during the war were tried. They focused on physicians who conducted inhumane and unethical human experiments in concentration camps, in addition to those who were involved in over 3,500,000 sterilizations of German citizens.[3][4]"

（４）"Several of the accused argued that their experiments differed little from those used before the war, and that there was no law that differentiated between legal and illegal experiments. This worried Drs. Andrew Ivy (1893-1978) and Leo Alexander, who worked with the prosecution during the trial. In April 1947, Dr. Alexander submitted a memorandum to the United States Counsel for War Crimes outlining six points for legitimate medical research.[5]"

（５）"On August 20, 1947, the judges delivered their verdict against Karl Brandt and 22 others.[6] The verdict reiterated the memorandum's points and, in response to expert medical advisers for the prosecution, revised the original six points to ten. The ten points became known as the "Nuremberg Code", which includes such principles as informed consent and absence of coercion; properly formulated scientific experimentation; and beneficence towards experiment participants. It is thought to have been mainly based on the Hippocratic Oath, which was interpreted as endorsing the experimental approach to medicine while protecting the patient.[7]"

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Copyleft, CC, Mitzub'ixi Quq Chi'j, 2019

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